BAAT Medical
BAAT Medical offers end-to-end solutions for medical device innovation, from strategy and funding to development, manufacturing, and regulatory compliance. They specialize in Class I-III devices, including implants and wearables, ensuring efficient market entry.
BAAT Medical is a comprehensive partner for medical device innovators, providing end-to-end solutions to bring cutting-edge technologies to market. They cater to a range of medical devices, from Class I to Class III, including instruments, wearables, (smart) implants, custom-made products, and medicinal combination devices. Their expertise spans the entire product lifecycle, starting with strategic evaluation of the device idea, market research, and business case development. They assist in securing funding, guiding startups and established companies through the financial landscape. The development phase is handled with a focus on turning concepts into tangible, market-ready products, ensuring innovative design and regulatory compliance. BAAT Medical also excels in manufacturing, scaling production to meet market demands while maintaining quality and readiness for approval. Furthermore, they offer robust regulatory affairs support, including navigating complex regulations like the MDR, and act as the Legal Manufacturer for custom-made devices, ensuring patient safety and compliance. Their proven process minimizes risks and optimizes for successful market entry or exits, helping clients achieve real-world impact in medical device innovation.
About
**Who they are**
BAAT Medical is an end-to-end solutions provider for medical device innovation, based in the Netherlands. They offer comprehensive support from initial strategy and funding through to development, manufacturing, and regulatory compliance.
**Expertise & scope**
* End-to-end medical device innovation support
* Strategy development, including Market Research & Market Entry, Business Case Development, and Key Industry Connections
* Funding acquisition support for entrepreneurs, startups, and technology transfer offices
* Product development and streamlining manufacturing processes
* Regulatory compliance, including acting as the Legal Manufacturer for MDR-compliant 3D-printed devices (Class IIa)
* Specialization in Class I-III devices, including implants and wearables
* Support for market entry, particularly in the EU and US
**Reputation / proof points**
* Acts as the Legal Manufacturer for MDR-approved 3D-printed custom-made devices, issuing a Statement Annex XIII.
* Partnership with 3DMM for MDR-compliant manufacturing of 3D-printed devices.
BAAT Medical is an end-to-end solutions provider for medical device innovation, based in the Netherlands. They offer comprehensive support from initial strategy and funding through to development, manufacturing, and regulatory compliance.
**Expertise & scope**
* End-to-end medical device innovation support
* Strategy development, including Market Research & Market Entry, Business Case Development, and Key Industry Connections
* Funding acquisition support for entrepreneurs, startups, and technology transfer offices
* Product development and streamlining manufacturing processes
* Regulatory compliance, including acting as the Legal Manufacturer for MDR-compliant 3D-printed devices (Class IIa)
* Specialization in Class I-III devices, including implants and wearables
* Support for market entry, particularly in the EU and US
**Reputation / proof points**
* Acts as the Legal Manufacturer for MDR-approved 3D-printed custom-made devices, issuing a Statement Annex XIII.
* Partnership with 3DMM for MDR-compliant manufacturing of 3D-printed devices.
Additional information
BAAT Medical emphasizes its role in navigating complex regulatory landscapes, particularly for custom-made 3D-printed medical devices under the MDR. They clarify the Legal Manufacturer's responsibility, providing a Statement Annex XIII to confirm MDR compliance for products manufactured through their validated processes. This service is crucial for 3D print labs and hospitals seeking to ensure accountability and patient safety when ordering custom surgical guides and similar devices. Their expertise extends to evaluating the viability of medical device ideas and securing necessary funding before development and certification.
Key Highlights
-
BAAT Medical acts as the Legal Manufacturer for MDR-compliant custom-made 3D-printed medical devices, issuing a Statement Annex XIII.
Source
“BAAT Medical acts as the Legal Manufacturer, ensuring full compliance with the Medical Device Regulation (MDR). BAAT validated the process and created a technical file and now issues a Statement Annex XIII with each product, confirming its MDR compliance.”
-
Offers end-to-end solutions for medical device innovation, covering strategy, funding, development, manufacturing, and regulatory compliance.
Source
“From crafting your strategy, developing your product, streamlining manufacturing and delivering your product everywhere while ensuring ongoing compliance.”
-
Specializes in Class I-III medical devices, including implants and wearables.
Source
“They specialize in Class I-III devices, including implants and wearables, ensuring efficient market entry.”
Certifications & Trust Signals
-
Headquartered in The Netherlands, serving the EU market.
Source
“F. Hazemeijerstraat 800 – Building A04 7555 RJ Hengelo The Netherlands”
Buyer Snapshot
Best for
- Medical device startups seeking end-to-end support
- Companies needing regulatory strategy and compliance
- Manufacturers of custom 3D-printed medical devices requiring MDR compliance
How engagement typically works
- End-to-end partnership
- Strategic advisory
- Regulatory execution
Typical deliverables
- Regulatory strategy and compliance documentation
- Funding acquisition support
- Market entry plans
- Statement Annex XIII for MDR-compliant devices
Good to know
- Best when requiring specialized support for Class I-III devices, including implants and wearables.
- Most effective for custom-made 3D-printed devices needing MDR compliance.
HQ:
Hengelo, Netherlands
Languages:
English, Dutch
Timezones:
Europe/Amsterdam
Claim status:
Listed
Services & Capabilities
Find PRRC Services | EU MDR/IVDR Providers & Quotes
Jurisdictions:
EU
Countries:
US, EU
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
26-100
Onboarding time:
3–14 days
Pricing model:
Onboarding + annual retainer
Starting from:
EUR 3,200
Included services:
PRRC appointment support, Lifecycle compliance oversight, Change-impact escalation, PMS/vigilance coordination support
Named PRRC:
Yes
Device Classes Supported:
Class I, Class IIa
PRRC Qualification Summary:
BAAT Medical acts as the Legal Manufacturer, ensuring full compliance with the Medical Device Regulation (MDR). BAAT validated the process and created a technical file and now issues a Statement Annex XIII with each product, confirming its MDR compliance. Hospitals retain responsibility for clinical use, but BAAT shoulders the accountability as the Legal Manufacturer, ending the back-and-forth confusion. This MDR-approved route designates BAAT as the responsible party, safeguarding patient safety and ensuring regulatory compliance in healthcare. The question of “Who is the Legal Manufacturer?” is now solved with BAAT Medical as the Legal Manufacturer and 3DMM as the production expert, this partnership delivers MDR-compliant custom-made devices with transparency and trust.
Additional prrc_service Details
Included Services Detailed
Appointment and mandate support for outsourced PRRC coverage (seed scope), Lifecycle compliance oversight aligned to Article 15 activities (seed scope), Change-impact triage and escalation support (seed scope), Periodic compliance reporting to management (seed scope)
Excluded Services
Notified Body decision-making on conformity assessment, Acting as Legal Manufacturer unless separately contracted, Commercial distribution or importer/distributor operations
Onboarding Steps
Implied process involves evaluating value proposition, performing a Business Scan, and developing strategy before product development and regulatory steps.
Coverage Details
PRRC availability set to Extended hours with defined escalation path (seed summary).
Device Classes Supported
Class I, IIa, IIb, III
Supports MDR
Yes
Supports IVDR
No
PRRC Qualification Summary
Acts as Legal Manufacturer for MDR-compliant devices, validating processes and creating technical files.
Regulatory Experience
Expertise in regulatory compliance, market entry, and acting as Legal Manufacturer for specific device types.
